Summary Safety Review - Ear and Forehead (contact) Infrared Thermometers (various brands) - Assessing the potential risk of inaccuracy in children under 2 years old

May 3, 2017

Product

Infrared thermometers

Potential Safety Issue

Inaccuracy in children under 2 years old

Key Messages

• Infrared (IR) thermometers are widely available in drug stores across Canada. These products are often used at home to measure temperature in children.
• Health Canada reviewed the risk of these thermometers giving inaccurate temperatures of children under 2 years old because of new information that became available. Previously, in 2009, Health Canada published a Notice stating that infrared thermometers should not be used in children under 2 years old.
• Health Canada's review concluded that there is new information (literature and clinical guidance) to show that ear and forehead contact IR thermometers are appropriate for use in children under 2 years old. Health Canada will now consider requests from these manufacturers to recommend use in this age group on labels. However, information is still lacking for non-contact IR thermometers, so this type is not recommended for use in children under 2 years old.
• Health Canada will continue to monitor scientific literature and clinical information about the accuracy of IR thermometers in children under 2 years old.

Overview

Health Canada reviewed the risk of IR thermometers being inaccurate when checking the temperature of children under 2 years old because of new information that became available. At the time of the review, IR thermometers were not recommended to be used in children under 2 years old. Note that there was not enough information gathered in this review for non-contact forehead thermometers, so the recommendations from this review apply to only contact forehead and ear IR thermometers.

Use in Canada

• IR thermometers are used in the ear or on the forehead to measure a person's body temperature.
• IR-sensing ear canal thermometers detect heat (IR energy) coming from the ear canal and ear drum (tympanic membrane).
• There are 2 types of forehead (temporal artery) IR sensing skin surface thermometers: contact and non-contact. Forehead contact thermometers measure the highest temperature while the thermometer is being moved across the skin. Forehead non-contact thermometers are held near the skin to measure the highest temperature from the forehead.

Safety Review Findings

• At the time of the review, Health Canada received 2 reports (1 in 1999 and 1 in 2005) related to mistaken (lower) temperature readings, both reports involved IR ear thermometers. In the 1999 report, the parents of a 2-month old infant were not able to detect what they thought may have been a fever. The parents waited until the next morning to go to the hospital. By that time, the infant's fever was very high and the child went into septic shock. The infant recovered after receiving fluids and antibiotics. In the 2005 report, there were no ill effects described.
• There has only been 1 recall of IR thermometers in the past 10 years related to mistakes in the temperature display where temperatures being shown on the thermometer were lower than real body temperatures. There were no ill effects related to this recall reported to Health Canada.
• Recent literature suggests that IR ear thermometer measurements are accurate when used in children under 1 year old. Both forehead contact and ear IR measurements were found to be accurate in feverish children. The measurements from forehead contact thermometers were the most similar to the measurements from rectal thermometers, which are thought to be the most accurate way to measure the temperature in young children. Literature suggests that ear IR thermometer measurement may be appropriate in hospitals for screening children.
• This review concluded that the overall benefits of using forehead contact IR thermometers outweigh the risks, especially when the use of other types of thermometers may be more difficult (for example, the use of rectal thermometers) in young children.

Conclusions and Actions

• Health Canada's review concluded that there is new information (literature and clinical guidance) to show that ear and forehead contact IR thermometers are appropriate for use in children under 2 years old. Health Canada will now consider requests from these manufacturers to recommend use in this age group on labels. However, information is still lacking for non-contact IR thermometers, so this type is not recommended for use in children under 2 years old.
• Health Canada encourages consumers and healthcare professionals to report any side effects related to inaccurate temperature readings from the use of these devices.
• Health Canada will continue to monitor safety information involving temperature inaccuracies with IR thermometers, as it does for all medical devices on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of these devices both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.